On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
EMA launches new version of EudraCT
On 11 October 2013, the European Medicines Agency ("EMA") launched a new version of the European Clinical Trials Database ("EudraCT") This new Version 9 permits clinical trial sponsors to submit summaries of the trial results to the EudraCT database. Version 9 of EudraCT is the first step towards the public disclosure of summaries of clinical trial results.
EudraCT is an electronic database containing protocol-related information on all on-going or completed clinical trials conducted in the European Union ("EU"). Its intention is to facilitate exchange of information between clinical trial sponsors, national competent authorities, the EMA and the European Commission. All clinical trials conducted in the EU must be registered with EudraCT before related Ethics Committee opinion and competent authority approval is sought. The database also includes information concerning clinical trials conducted in third countries if these are included in a paediatric investigation plan ("PIP") supporting an application for marketing authorisation for a medicinal product in the EU.
Some of the information in EudraCT is made accessible to the public through the EU Clinical Trials Register website ("EU CTR"). The EU CTR website, launched on 22 March 2011, permits the public to search for information concerning interventional clinical trials registered in EudraCT. The EU CTR currently contains information concerning the design of each clinical trial, the clinical trial sponsor, the investigational medicinal products, therapeutic areas involved and the status of the clinical trial.
Summaries of the results of clinical trials should also be made publicly available through EU CTR in the future. The launch of Version 9 of EudraCT is the first step in this direction.
Publication of information concerning the results of clinical trials
At the moment, clinical trial sponsors are encouraged by the EMA to voluntarily add summaries of the results of completed clinical trials to the newly launched Version 9 of the EudraCT database. The summaries should include information concerning clinical trial patients, the investigational medicinal product, primary and secondary endpoints, adverse events and discussion and interpretation of the study results by the sponsor or the national competent authorities.
As a next step, the EMA will launch a new version of EU CTR. As soon as this new version of EU CTR is launched, the summaries of clinical trial results that were voluntarily submitted by the clinical trial sponsors to Version 9 of EudraCT will automatically be made publically available on the EU CTR. The launch of the new version of the EU CTR is foreseen for late 2013.
The EMA will publish further updates of the EudraCT in the second and third quarters of 2014. These updates will improve the mechanisms for adding summaries of the results of completed clinical trials to EudraCT.
After the expected implementation of these updates in the third quarter of 2014, clinical trial sponsors will be required to add summaries of the results of completed clinical trials to EudraCT in accordance with the timelines provided in a guidance issued by the European Commission. Summaries of the results of completed clinical trials must be added to EudraCT within one year following the end of the trial. This time period is reduced to six months for paediatric clinical trials.
 Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006; available at http://ec.europa.eu/health/files/eudralex/vol-10/2012_302-03/2012_302-03_en.pdf
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